LAP SPNG, 4X18, STRL

Description of Event or Problem

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025 ¿ (B)(6) 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: MATERIAL FRAYED. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 2 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS): 2 DEVICES: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE PRODUCT DISPOSITION: 2 DEVICES: PRODUCT DISPOSITION IS NOT YET DETERMINED ADDITIONAL INFORMATION: 2 DEVICES WERE LABELED FOR SINGLE-USE. 2 DEVICES WERE NOT REPROCESSED OR REUSED.